Job Desk
- Responsible for QA responsible pharmacist.
- Review batch record including analytical report and other document related such as marketing authorization, product speciffication, retained sample check, OOS/OOT/event/deviation/change control.
- Review and approval of Good Manufacturing Practice (GMP) document at Plant, perform quality oversight, establish CCS.
- Review and approval all document related with technology transfer.
- Review and approval all the Good Manufacturing Practice (GMP) document for registration purposes (dossier).
- Create prosedure and system, perform data integrity audit to area.
- Create system and collecting and create summary for quality key performance indicator.
Requirements
- Bachelor’s degree of pharmacy (apothecary).
- Minimum of 10 years of experience in managerial level.
- Have a experience in global company.
- Understand about CGMP and quality management system.
- Have a experience in steril facility.
- Excellent leadership, communication, and problem solving skills.
